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Process for Casting and Extracting Biomedical Devices

a biomedical device and polymer technology, applied in the field of casting polymer biomedical devices, can solve the problems of affecting optical clarity or irritating the eye, the lens-forming monomer may not be fully polymerized, and the isopropanol is relatively flammable, so as to improve the safety of manufacturing processes and facilitate the disposal. , the effect of less flammability

Inactive Publication Date: 2007-06-21
BAUSCH & LOMB INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent describes an improved process for making biomedical devices, specifically ophthalmic devices like contact lenses. The process involves casting a mixture of monomers and then removing any extractables from the devices by contacting them with a diluent. The diluent has specific properties, including a high flash point, low vapor pressure, and high boiling point. The process can be used with different types of monomers and can involve immersing the devices in the diluent or replacing the diluent with water. The use of the diluent helps to improve the quality and efficiency of the process.

Problems solved by technology

Additionally, some of these lens-forming monomers may not be fully polymerized, and oligomers may be formed from side reactions of the monomers, these unreacted monomers and oligomers remaining in the polymeric article.
Such residual materials may affect optical clarity or irritate the eye when the ophthalmic article is worn or implanted, so generally, the articles are extracted to remove the residual materials.
Although solvents such as isopropanol have proven very effective in extracting undesired residual materials from polymeric biomedical devices, isopropanol is relatively flammable, having a flash point of 11° C.; additionally, it is relatively expensive to dispose of isopropanol.
Further, if all isopropanol is not removed or rinsed from the device, the eye irritation may result.

Method used

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  • Process for Casting and Extracting Biomedical Devices
  • Process for Casting and Extracting Biomedical Devices
  • Process for Casting and Extracting Biomedical Devices

Examples

Experimental program
Comparison scheme
Effect test

example 1a

Lens Casting

[0081] A monomer mixture was prepared from the components listed in Table 1. The amounts in Table 1 are parts by weight unless otherwise noted. The monomer mixture was placed between anterior and posterior contact lens molds, and thermally cured in a nitrogen-filled oven at 110° C. Following curing, the posterior mold sections were removed, and the contact lenses were released from the anterior mold sections.

TABLE 1ComponentParts by WeightID2S4H11TRIS35DMA11NVP40HemaVC0.5Hema5DEGMBE3IMVT150 ppmUV-Agent0.5Initiator0.5

example 1b

Lens Extraction

[0082] The contact lenses were weighed, and then submersed into 1.2 mL of the solvents listed in Table 2. After the noted period of extraction, the lenses were removed from the solvent and placed in 2 mL deionized water for 30 minutes. The lenses were removed from the water, dried overnight in a vacuum oven at 80° C., and then weighed again. The percentage of weight loss is recorded as percent extractables. For each entry in Table 2, batches of six lenses were tested collectively. The first entry in Table 1 served as a control since extraction in isopropyl alcohol (IPA) for sixteen hours should approach removal of all extractables.

TABLE 2SolventExtraction Time% ExtractablesIPA16 hours5.34IPA60 minutes5.05IPA / Water (50 / 50)60 minutes2.48Water60 minutes2.46DEGMBE60 minutes4.2DEGMBE / Water (50 / 50)60 minutes2.22

[0083] As seen in Table 2, diethylene glycol monobutyl ether was effective for extracting silicone hydrogel contact lenses cast from monomeric mixtures including ...

example 2a

Lens Casting

[0084] A monomer mixture was prepared from the components listed in Table 3. The amounts in Table 3 are parts by weight unless otherwise noted. The monomer mixture was placed between anterior and posterior contact lens molds, and thermally cured in a nitrogen-filled oven at 110° C. Following curing, the posterior mold sections were removed, and the contact lenses were released from the anterior mold sections.

TABLE 3ComponentParts by WeightID2S4H11TRIS35DMA11NVP40HemaVC0.5Hema53M1B3IMVT150 ppmUV-Agent0.5Initiator0.5

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Abstract

A process for producing polymeric biomedical devices, such as contact lenses, involves casting a monomeric mixture including a diluent; and subsequently removing extractables from the devices by contacting the devices with the an additional volume of the diluent.

Description

[0001] This application claims the benefit of Provisional Patent Application No. 60 / 752,568 filed Dec. 21, 2005 and is incorporated herein by reference.FIELD OF THE INVENTION [0002] The present invention relates to a process for casting polymeric biomedical devices, particularly ophthalmic devices including contact lenses, intraocular lenses and ophthalmic implants, and for removing extractables from such devices. BACKGROUND OF THE INVENTION [0003] Hydrogels represent a desirable class of materials for the manufacture of various biomedical devices, including contact lenses. A hydrogel is a hydrated cross-linked polymeric system that contains water in an equilibrium state. Hydrogel lenses offer desirable biocompatibility and comfort. [0004] In a typical process for the manufacture of hydrogel polymeric ophthalmic devices, such as contact lenses, a composition containing a mixture of lens-forming monomers is charged to a mold and cured to polymerize the lens-forming monomers and form ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): B29D11/00
CPCB29D11/00125G02B1/043
Inventor LAI, YU-CHINQUINN, EDMOND T.WILSON, ALAN C.
Owner BAUSCH & LOMB INC